Healthy VolunteersPhase 3XEPONCT02129400
Influence on Erythropoetin-level by Xenon
A Phase 3 study testing Xenon pro Anaesthesia 100 % (V/V) and Aer medicinalis Linde 100% in people with Healthy Volunteers, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation. Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Xenon pro Anaesthesia 100 % (V/V) and Aer medicinalis Linde 100%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to Jan 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male subjects
- Age: > 18 years
- legally competent to sign
- without any known medical condition or medication prescribed at the University Hospital RWTH Aachen, Germany
- Persons that are able and willing to understand and follow the instructions of the study personnel
- Signed informed consent
Who cannot join
- Smoker, alcoholic or person who regularly consumes drugs or medication
- Persons with a medical condition that is contraindicated with the planned treatment
- Known hypersensitivity against xenon
- Persons not legally competent to sign
- Simultaneous participation at any other trial
- Blood-loss due to trauma during the period of the study or 2 months previous
- Blood donation during the period of the study or 2 months previous
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen, Department for Anesthesia
Aachen, North-Rhine Westfalia, 52074
About this study
Official title: Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers
The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation.
Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood
Read the detailed description
Xenon-gas is an approved anesthetic by the EMEA and is used for a balanced anesthesia in combination with opioids for adults with a american society of anesthesiology classification ASA ≤ III. Several clinical and pre-clinical studies have shown a positive effect of xenon on several organ functions such as in brain, kidneys and heart. In two studies, an enhanced expression of hypoxia inducible factor-1α (HIF-1α) could be shown in animal kidneys and kidney cells. Interestingly, HIF-1α leads to an enhanced formation of erythropoetin (EPO). This might result in an enhanced oxygen transport capacity and an enhanced oxygen-level after xenon-treatment.
Aim of the project is to analyze the effect of xenon-inhalation on circulating erythropoetin-level in blood of healthy volunteers in a randomized controlled pilot study. Besides, other positive stimulating factors for erythropoiesis (such as HIFa stabilizing factors) and growth factors (such as fibroblast growth factors (FGFs), hepatocyte growth factor (HGF), mechano growth factors (MGFs), platelet-derived growth factors (PDGFs), vascular endothelial growth factors (VEGFs)) shall be analyzed.
- Conditions
- Healthy Volunteers
- Being tested
- Xenon pro Anaesthesia 100 % (V/V), Aer medicinalis Linde 100%
- Keywords
- Xenon-inhalation, Erythropoetin, Pharmakokinetic, Pharmacodynamic, Hemodynamic parameters, Inflammatory parameters, Growth factors, Oxidative stress parameters
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon pro Anaesthesia 100 % (V/V)Drug
Also called licence number: 56582.00.00
Xenon-gas inhalation of indicated concentrations during indicated time
Aer medicinalis Linde 100%Drug
Also called Pharmakotherapeutic group: medical gas, Licence number: 68885.00.00, ATC-Code: V03AN05
| Study group | Role | What they receive |
|---|---|---|
| 10min Xenon 15%, FiO2 75% | Experimental | 10 minutes of 15 % xenon-inhalation (with 75 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 10min Xenon 30%, FiO2 60% | Experimental | 10 minutes of 30 % xenon-inhalation (with 60 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 30min Xenon 15%, FiO2 75% | Experimental | 30 minutes of 15 % xenon-inhalation (with 75 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 30min Xenon 30%, FiO2 60% | Experimental | 30 minutes of 30 % xenon-inhalation (with 60 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 45min Xenon 15%, FiO2 75% | Experimental | 45 minutes of 15 % xenon-inhalation (with 75 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 45min Xenon 30%, FiO2 60% | Experimental | 45 minutes of 30 % xenon-inhalation (with 60 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 90min Xenon 15%, FiO2 75% | Experimental | 90 minutes of 15 % xenon-inhalation (with 75 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 90min Xenon 30%, FiO2 60% | Experimental | 90 minutes of 30 % xenon-inhalation (with 60 % FiO2) Receives: Drug: Xenon pro Anaesthesia 100 % (V/V) |
| 10min air medicinalis, FiO2 75% | Placebo comparator | 10 minutes of air medicinalis (with 75 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
| 10min air medicinalis, FiO2 60% | Placebo comparator | 10 minutes of air medicinalis inhalation (with 60 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
| 30min air medicinalis, FiO2 75% | Placebo comparator | 30 minutes of air medicinalis inhalation (with 75 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
| 30min air medicinalis, FiO2 60% | Placebo comparator | 30 minutes of air medicinalis inhalation (with 60 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
| 45min air medicinalis, FiO2 75% | Placebo comparator | 45 minutes of air medicinalis inhalation (with 75 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
| 45min air medicinalis, FiO2 60% | Placebo comparator | 45 minutes of air medicinalis inhalation (with 60 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
| 90min air medicinalis, FiO2 75% | Placebo comparator | 90 minutes of air medicinalis inhalation (with 75 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
| 90min air medicinalis, FiO2 60% | Placebo comparator | 90 minutes of air medicinalis inhalation (with 60 % FiO2) Receives: Drug: Aer medicinalis Linde 100% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total
Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total.
Timepoints of measurement:
Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation
Measured: up to 216 hrs after first xenon-application
Secondary outcomes (1)
First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy
Timepoints of measurement:
Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation
Measured: up to 216 hrs after the first xenon-application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: The analysis of the blood samples was much expensive than calculated. The recruitment had to be stopped after 36 study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf Rossaint, Prof. M.D., Principal investigator, University Hospital RWTH Aachen, Department for Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02129400
- Sponsor's protocol ID
- 14-026
- Other IDs
- 2014-000973-38, 2014
- Acronym
- XEPO
- Status last verified
- Mar 2015
- First submitted
- 15 Apr 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xenon-inhalation: Elimination of Xenon and Its Effect on Erythropoetin Levels in Blood of Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02129400
- Acronym / sponsor ID
- XEPO / 14-026
- Conditions
- Healthy Volunteers
- Keywords
- Xenon-inhalation, Erythropoetin, Pharmakokinetic, Pharmacodynamic, Hemodynamic parameters, Inflammatory parameters, Growth factors, Oxidative stress parameters
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The analysis of the blood samples was much expensive than calculated. The recruitment had to be stopped after 36 study participants.
- Enrolment
- 36 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation.
Hypothesis: Xenon-inhalation enhances erythropoetin-levels in blood
Detailed description
Xenon-gas is an approved anesthetic by the EMEA and is used for a balanced anesthesia in combination with opioids for adults with a american society of anesthesiology classification ASA ≤ III. Several clinical and pre-clinical studies have shown a positive effect of xenon on several organ functions such as in brain, kidneys and heart. In two studies, an enhanced expression of hypoxia inducible factor-1α (HIF-1α) could be shown in animal kidneys and kidney cells. Interestingly, HIF-1α leads to an enhanced formation of erythropoetin (EPO). This might result in an enhanced oxygen transport capacity and an enhanced oxygen-level after xenon-treatment.
Aim of the project is to analyze the effect of xenon-inhalation on circulating erythropoetin-level in blood of healthy volunteers in a randomized controlled pilot study. Besides, other positive stimulating factors for erythropoiesis (such as HIFa stabilizing factors) and growth factors (such as fibroblast growth factors (FGFs), hepatocyte growth factor (HGF), mechano growth factors (MGFs), platelet-derived growth factors (PDGFs), vascular endothelial growth factors (VEGFs)) shall be analyzed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| 10min Xenon 15%, FiO2 75% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)10 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
| 10min Xenon 30%, FiO2 60% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)10 minutes of 30 % xenon-inhalation (with 60 % FiO2) |
| 30min Xenon 15%, FiO2 75% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)30 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
| 30min Xenon 30%, FiO2 60% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)30 minutes of 30 % xenon-inhalation (with 60 % FiO2) |
| 45min Xenon 15%, FiO2 75% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)45 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
| 45min Xenon 30%, FiO2 60% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)45 minutes of 30 % xenon-inhalation (with 60 % FiO2) |
| 90min Xenon 15%, FiO2 75% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)90 minutes of 15 % xenon-inhalation (with 75 % FiO2) |
| 90min Xenon 30%, FiO2 60% | Experimental | Drug: Xenon pro Anaesthesia 100 % (V/V)90 minutes of 30 % xenon-inhalation (with 60 % FiO2) |
| 10min air medicinalis, FiO2 75% | Placebo comparator | Drug: Aer medicinalis Linde 100%10 minutes of air medicinalis (with 75 % FiO2) |
| 10min air medicinalis, FiO2 60% | Placebo comparator | Drug: Aer medicinalis Linde 100%10 minutes of air medicinalis inhalation (with 60 % FiO2) |
| 30min air medicinalis, FiO2 75% | Placebo comparator | Drug: Aer medicinalis Linde 100%30 minutes of air medicinalis inhalation (with 75 % FiO2) |
| 30min air medicinalis, FiO2 60% | Placebo comparator | Drug: Aer medicinalis Linde 100%30 minutes of air medicinalis inhalation (with 60 % FiO2) |
| 45min air medicinalis, FiO2 75% | Placebo comparator | Drug: Aer medicinalis Linde 100%45 minutes of air medicinalis inhalation (with 75 % FiO2) |
| 45min air medicinalis, FiO2 60% | Placebo comparator | Drug: Aer medicinalis Linde 100%45 minutes of air medicinalis inhalation (with 60 % FiO2) |
| 90min air medicinalis, FiO2 75% | Placebo comparator | Drug: Aer medicinalis Linde 100%90 minutes of air medicinalis inhalation (with 75 % FiO2) |
| 90min air medicinalis, FiO2 60% | Placebo comparator | Drug: Aer medicinalis Linde 100%90 minutes of air medicinalis inhalation (with 60 % FiO2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male subjects
- Age: > 18 years
- legally competent to sign
- without any known medical condition or medication prescribed at the University Hospital RWTH Aachen, Germany
- Persons that are able and willing to understand and follow the instructions of the study personnel
Key exclusion criteria (7 listed)
- Smoker, alcoholic or person who regularly consumes drugs or medication
- Persons with a medical condition that is contraindicated with the planned treatment
- Known hypersensitivity against xenon
- Persons not legally competent to sign
- Simultaneous participation at any other trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon pro Anaesthesia 100 % (V/V)Also: licence number: 56582.00.00Xenon-gas inhalation of indicated concentrations during indicated time | Drug | 10min Xenon 15%, FiO2 75%, 10min Xenon 30%, FiO2 60%, 30min Xenon 15%, FiO2 75%, 30min Xenon 30%, FiO2 60%, 45min Xenon 15%, FiO2 75%, 45min Xenon 30%, FiO2 60%, 90min Xenon 15%, FiO2 75%, 90min Xenon 30%, FiO2 60% |
| Aer medicinalis Linde 100%Also: Pharmakotherapeutic group: medical gas, Licence number: 68885.00.00, ATC-Code: V03AN05 | Drug | 10min air medicinalis, FiO2 60%, 10min air medicinalis, FiO2 75%, 30min air medicinalis, FiO2 60%, 30min air medicinalis, FiO2 75%, 45min air medicinalis, FiO2 60%, 45min air medicinalis, FiO2 75%, 90min air medicinalis, FiO2 60%, 90min air medicinalis, FiO2 75% |
Primary outcome
Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total
Time frame: up to 216 hrs after first xenon-application
Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total. Timepoints of measurement: Before each inhalation, Directly after the first inhalation, 2 hrs after the first inhalation, 4 hrs after the first inhalation, 8 hrs after the first inhalation, 22-24 hrs after each inhalation, 46-48 hrs after each inhalation, 70-72 hrs after the last inhalation, 94-96 hrs after the last inhalation, 118-120 hrs after the last inhalation
1 secondary outcome
First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spectroscopy
Time frame: up to 216 hrs after the first xenon-application
Results and safety
The study was stopped early (reason given: The analysis of the blood samples was much expensive than calculated. The recruitment had to be stopped after 36 study participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Rossaint, Prof. M.D. principal investigator
University Hospital RWTH Aachen, Department for Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xenon pro Anaesthesia 100 % (V/V) and Aer medicinalis Linde 100% in people with Healthy Volunteers, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The analysis of the blood samples was much expensive than calculated. The recruitment had to be stopped after 36 study participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in erythropoetin-level in blood of healthy volunteers up to 216 hrs after the first of three xenon applications in total (time frame: up to 216 hrs after first xenon-application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.